EMBLEM MRI S-ICD Model A219
Reported: February 17, 2021 Initiated: December 2, 2020 #Z-0951-2021
Product Description
EMBLEM MRI S-ICD Model A219
Reason for Recall
Electrical overstress may lead to device malfunction.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 872 units
- Distribution
- Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
EMBLEM MRI S-ICD Model A219. Recalled by Boston Scientific Corporation. Units affected: 872 units.
Why was this product recalled? ▼
Electrical overstress may lead to device malfunction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Critical. Recall number: Z-0951-2021.
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